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Presenters will discuss how patient input and real world evidence can be used to meet the "adequate and well-controlled studies" standard. The panel will discuss the meaning of the science of patient input, and provide examples of successfully using patient input (e.g., in making trial endpoint decisions; weighing benefit/risk; modifying study protocols based on patient input, etc.) within the regulatory context to enhance drug development and approval by incorporating the patient voice. Gaps and challenges with suggested solutions will be discussed, and differences among US and non-US regulatory agencies may be considered.

Learning Objectives

Define the science of patient input; Describe the challenges and solutions to successfully incorporating the patient voice into drug development.

Chair

Roslyn F Schneider

Speaker

Evolving Methods of Including Patients' Input in Drug Development Roslyn F Schneider

Roslyn Schneider, Global Patient Affairs Lead at Pfizer drives more systematic patient centricity throughout the medicine development lifecycle. She held other roles in Medical Affairs, Medical Strategy and Development at Pfizer since 2006. Roz is an Internist, Pulmonologist, Int... Read More →

Bennett Levitan, MD-PhD is Senior Director, Dept of Epidemiology at Janssen R&D. He introduced state of the art patient-focused benefit-risk assessment to Janssen and has led numerous teams in preparation of benefit-risk assessments. He co-led development of the PhRMA BRAT Framew... Read More →

Kevin Marsh is Executive Director of Outcomes Research for Evidera. His research interests include using MCDA and quantitative preference data to inform health decisions, including pipeline optimisation, authorisation, reimbursement, and prescription decisions. He actively contri... Read More →

Roslyn Schneider, Global Patient Affairs Lead at Pfizer drives more systematic patient centricity throughout the medicine development lifecycle. She held other roles in Medical Affairs, Medical Strategy and Development at Pfizer since 2006. Roz is an Internist, Pulmonologist, Int... Read More →